Phase 3 Safety Study of MoxDuo IR for Postoperative Pain

QRxPharma Limited announced additional data from its Phase 3 safety study of MoxDuo IR for the treatment of patients experiencing moderate to severe postoperative pain following bunionectomy surgery. Study 022 compared the respiratory effects of MoxDuo IR to equianalgesic doses of either morphine or oxycodone in 375 patients. QRxPharma analyzed data from patients experiencing the worst (10th percentile) of all observed oxygen desaturations, and the results demonstrated that the risk of the occurrence of such potentially dangerous desaturations was significantly greater in patients receiving morphine (P<0.009) or oxycodone (P<0.002) alone than in those receiving MoxDuo. Such desaturations occurred in 12% of the morphine, 15% of the oxycodone and 3% of the MoxDuo-treated patients. These findings translate to a relative risk ratio of approximately 4:1 or 5:1 for either the morphine or oxycodone vs. MoxDuo.

The company remains on track to file its New Drug Application (NDA) for MoxDuo IR with the FDA in August 2011.